CEDH · CASELAW;JUDGMENTS;CHAMBER;ENG — 8 février 2022

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display:inline-block } .s434D37A9 { margin-top:0pt; margin-bottom:0pt; text-indent:14.2pt; text-align:justify; page-break-inside:avoid; page-break-after:avoid } .sD11CFAB7 { margin-top:14pt; margin-left:15.01pt; margin-bottom:3pt; text-align:justify; padding-left:1.99pt; font-family:Arial } .sFBC99493 { font-style:italic } .s51DFF5CF { margin-top:0pt; margin-left:34pt; margin-bottom:0pt; text-indent:-17pt; text-align:justify } .sE5BF05B1 { width:2.33pt; font:7pt 'Times New Roman'; display:inline-block } .s2D9C6089 { margin-top:12pt; margin-bottom:12pt; text-indent:14.2pt; text-align:justify; page-break-inside:avoid; page-break-after:avoid } .s69DCC830 { margin-top:36pt; margin-bottom:0pt } .s53D4691F { width:35.23pt; display:inline-block } .s6B870CDD { width:153.11pt; display:inline-block } .s5D826FD4 { width:25.88pt; display:inline-block } .s1B61D60 { width:156.43pt; display:inline-block }   FOURTH SECTION CASE OF BOTOYAN v. ARMENIA (Application no. 5766/17)       JUDGMENT Art 8 • Private life • Positive obligations • Insufficient evidence demonstrating that the identified deficiencies in the regulatory healthcare framework led or contributed to the applicant’s disability • Existing legal framework for obtaining a patient’s informed consent not defective • Lack of access to an effective procedure enabling applicant to bring medical malpractice claim and obtain compensation   STRASBOURG 8 February 2022   FINAL   08/05/2022   This judgment has become final under Article 44 § 2 of the Convention. It may be subject to editorial revision.   In the case of Botoyan v. Armenia, The European Court of Human Rights (Fourth Section), sitting as a Chamber composed of:   Yonko Grozev, President,   Tim Eicke,   Iulia Antoanella Motoc,   Armen Harutyunyan,   Pere Pastor Vilanova,   Jolien Schukking,   Ana Maria Guerra Martins, judges, and Ilse Freiwirth, Deputy Section Registrar, Having regard to: the application against the Republic of Armenia lodged with the Court under Article 34 of the Convention for the Protection of Human Rights and Fundamental Freedoms (“the Convention”) by an Armenian national, Ms   Marina Botoyan (“the applicant”), on 29 December 2016; the decision to give notice to the Armenian Government (“the Government”) of the application; the parties’ observations; Having deliberated in private on 11 March 2021 and 18 January 2022, Delivers the following judgment, which was adopted on that last-mentioned date: INTRODUCTION 1.     The case concerns the applicant’s complaints, under Article 8 of the Convention, that the State failed to comply with its regulatory duties, that failures in her treatment at a public hospital led to medical complications leaving her permanently disabled, and that she was not properly informed of the risks of the medical procedure she underwent. It also concerns her complaint that no effective mechanism was in place to enable her to obtain compensation for the damage suffered. THE FACTS 2.     The applicant was born in 1943 and lives in Artik. She was represented by Ms A. Melkonyan and Ms H. Harutyunyan, lawyers practising in Yerevan, and Ms A. Aghagyulyan , a legal expert. 3.     The Government were represented by their Agent, Mr G. Kostanyan, and subsequently by Mr Y. Kirakosyan, Representative of the Republic of Armenia to the European Court of Human Rights. 4.     The facts of the case may be summarised as follows. the applicant’s surgery and its complications 5.     On 6 February 2008 the applicant fell on the stairs and broke her left leg. 6.     On the same date she was taken by ambulance to Artik Medical Centre, a public hospital under the control of the Shirak regional authority. 7 .     According to the applicant’s medical file, she was admitted to Artik Medical Centre at 10.30 p.m. on 6 February 2008. The file further stated that the applicant had been admitted for inpatient treatment in the surgical department and was diagnosed with a closed comminuted fracture of the left distal tibia (lower leg bone) with significant displacement. 8.     On 7 February 2008 Dr A.A., a general surgeon at Artik Medical Centre, operated on the applicant. The surgery included the insertion of metal implants into her leg to stabilise the bone fracture. 9 .     The applicant’s medical file also stated the type of medical intervention, its date and time and the type of anaesthetic administered. According to the medical file, the applicant had been informed that she had received treatment under the public healthcare system. This was confirmed by her signature in the relevant part of the file. 10 .     According to the Government, prior to the surgery the applicant was informed orally of the consequences, in particular, that she would be able to walk but not in the same way as before. The Government averred that the applicant had also been informed that the surgery would be performed free of charge under the public healthcare system. The applicant partially contested this argument, claiming that she had only been informed of the financial aspects of the surgery but not as to the possible risks of the medical intervention. Nor had she been informed of the origin of the metal implants used – she had not been asked to pay for them and they had not been obtained under the public healthcare system. 11.     On 13 March 2008 the applicant was discharged. She was not provided with any medical documents attesting to her state of health. 12.     Following her discharge from hospital, the applicant remained under Dr A.A.’s supervision: he visited her several times at home, enquired about her condition and personally treated her wound. 13.     In the meantime, the applicant’s wound became infected, she suffered from fevers regularly and her leg started to hurt. 14 .     On 26 May 2008 the applicant was operated on by Dr K.K., a traumatologist at G.   Gyulbenkyan Surgical Hospital in Gyumri. During the operation the metal implants were removed from her leg. She remained under medical supervision for a month following discharge. The applicant’s complaints to the authorities 15 .     Thereafter the applicant sent complaint letters to various State officials and bodies, including the Ministry of Health, alleging that Dr A.A. was liable for the damage caused to her health. 16 .     On 12 October 2009 the Department of Health and Social Security of the Shirak regional authority (“the Department of Health”) held a consultation with the participation of the head and a divisional head of the Department of Health, the chief orthopaedic surgeon and the chief surgeon of the Shirak region, Dr A.A. and the head of Artik Medical Centre. The minutes of that consultation contained the names and signatures of the participants, reference to a complaint sent by the applicant to the National Assembly and a brief description of her medical history. The relevant parts of the minutes read as follows: “... On 07.02.2008 osteosynthesis with an orthopaedic plate and screw was performed. The surgery was performed correctly; fixation of the bone fracture was done with the use of State standard metal implantable devices ... At present the patient has post ‑ traumatic deformative osteoarthritis of the ankle joint ... Deformative osteoarthritis is a common complication for this type of inner joint fracture ... and has no connection to the surgery ...” 17 .     On 10 January 2010 the applicant qualified for permanent disability benefit, having been diagnosed with severe contracture of the left ankle after a lower leg bone fracture, with limited mobility of the lower limbs. 18 .     On 4 October 2010 the Department of Health held another consultation with the same participants (see paragraph 16 above), referring to a complaint sent by the applicant to the President of Armenia. The minutes of that consultation were similar in content to the minutes of the consultation held on 12 October 2009. the applicant’s criminal complaint 19 .     On 17 December 2013 the applicant lodged a criminal complaint against Dr A.A. for medical malpractice resulting in serious damage to her health. 20 .     On 26 December 2013 the police instituted criminal proceedings under Article 130 § 1 of the Criminal Code (medical negligence – see paragraph 47 below). 21.     On the same date the investigator ordered a forensic medical examination of the applicant. 22 .     In the course of the investigation Dr A.A. was questioned as a witness. He stated, in particular, that he had worked as a general surgeon at Artik Medical Centre since 1998. He had qualified as a general surgeon and in 2001 had been authorised by the Ministry of Health to practise general surgery. On 7 February 2008 he had operated on the applicant: bone fractures had been stabilised with metal orthopaedic plates and State standard screws. During surgical dressing, a collection of pus had been discovered, but this had cleared up and the applicant had been discharged in a good state of health. He had regularly visited her after her discharge from hospital and offered to surgically remove the metal implants, but she had refused, stating that she wished to have the operation performed in another hospital. 23 .     Dr K.K. was also questioned as a witness and stated, inter alia , that a collection of pus was a possible, undesirable and rare complication. Such a complication could appear in circumstances outside the practitioner’s control but it was necessary to inform the patient of the possible complications prior to surgery and ensure that the latter still consented to the intervention, a protocol which was mandatory abroad and had started to apply in Armenia a couple of years previously. 24 .     On 21 February 2014 a panel of forensic medical experts issued a report. The relevant parts read as follows: “... [the applicant’s] medical examinations, diagnoses and treatments were carried out correctly and in a timely manner. ... According to the medical records submitted, the first operation (osteosynthesis) was performed correctly but later a complication developed in the form of an infection which had brought about osteomyelitis, the reason for which is impossible to determine precisely at the present time ...” 25 .     In the course of the investigation G.H., a member of the expert panel, was questioned and stated, inter alia , that a number of factors could have contributed to the appearance of the osteomyelitis; it had therefore not been possible to identify its specific cause. According to medical data, metal implants could also be a cause of subsequent infection bringing about osteomyelitis since in any case they were a foreign body. 26 .     On 7 June 2014 the investigator decided to terminate the proceedings for lack of corpus delicti in Dr A.A.’s actions. The decision referred, inter alia , to the forensic medical report of 21 February 2014 (see paragraph 24 above), the records of the consultations of 12 October 2009 and 4 October 2010 held by the Department of Health (see paragraphs 16 and 18 above) and the statements of the applicant, Dr A.A., Dr K.K. and other doctors, including forensic expert G.H. (see paragraphs 22, 23 and 25 above). the applicant’s appeals 27 .     On 20 June 2014 the applicant appealed against the investigator’s decision to the prosecutor on the grounds that, inter alia , in the course of the investigation several issues had not been clarified, notably whether Dr A.A. had had the authority to perform the surgery, how long the metal implants should have stayed in the applicant’s body, her reasons for not wanting Dr   A.A. to surgically remove the implants, and the type of post-operative care she should have been provided with and by whom. In addition, she had not been informed of the possible complications that could arise from the surgery. 28 .     By a decision of 30 June 2014, the prosecutor dismissed the applicant’s appeal, finding, in particular, that it had been established that A.A., as a qualified doctor, had had the authority to perform the surgery in question and had done so correctly. 29.     On 25 August 2014, the applicant lodged an application for a judicial review of the investigator’s and prosecutor’s decisions of 7 and 30 June 2014 respectively (see paragraphs 26 and 28 above). 30 .     On 28 November 2014 the Shirak Regional Court (“the Regional Court”) fully upheld the investigating authorities’ decision not to prosecute Dr A.A. 31 .     The applicant lodged an appeal. She reiterated her previous arguments, including her complaints that she was not informed about the risks of the medical procedure she underwent at Artik Medical Centre and that Dr   A.A. was not qualified to perform the surgery in question. 32 .     On 18 February 2015 the Criminal Court of Appeal allowed the applicant’s appeal, quashed the Regional Court’s decision of 28 November 2014 (see paragraph 30 above) and returned the case file to the prosecution. The relevant parts of its decision read as follows: “... according to the material in the criminal case file, Dr [A.A.] is a qualified ‘general surgeon’ but not a specialist in ‘traumatology and orthopaedics’. That is to say [Dr   A.A.] did not have the authority to perform surgery on a person diagnosed with a ‘closed comminuted fracture of the left distal tibia (lower leg bone) with significant displacement’. ... the [forensic medical] experts had not been informed that, following her discharge, [the applicant] had been treated by [Dr A.A.], who had visited the patient regularly; documents attesting [to Dr A.A.’s] specialisation had not been submitted, therefore the experts did not have all the necessary information concerning the case at their disposal and their report cannot be considered to be full and accurate. Hence it is necessary to further question the experts to clarify the above-mentioned issues and, if necessary, to order an additional forensic medical examination by a medical panel. The forensic [medical] examination should also clarify whether ... the complications and the disability resulted from the doctor’s [surgery and post ‑ operative care].” Resumption of the investigation 33.     On 5 March 2015 the criminal proceedings were resumed. 34.     An additional forensic medical examination was ordered on 30 March 2015. 35 .     The investigator questioned Dr A.A. again as a witness. He submitted, in particular, that the metal implants used in the applicant’s surgery had been State standard and had not been acquired by Artik Medical Centre. At some point in 2007 a patient with a fracture had left him the metal implantable devices during a consultation and stated that they could be used for surgery on other patients. The metal implants in question, which had been new and disposable, had been used in the applicant’s surgery after disinfection. 36 .     On 15 July 2015 the panel of forensic medical experts delivered its report, the relevant parts of which read as follows: “... According to the medical records submitted and X-ray images ... [the applicant’s] examinations at Artik Medical Centre were carried out in a timely manner and the resulting ... diagnosis was correct. The surgical treatment offered to [the applicant], that is to say osteosynthesis with metal plates and screws, was indicated and, according to the X-ray images, generally performed correctly ... As regards the complications which arose at the post-operative stage ... not ruling out the probability of their development even in the event of quality specialist medical assistance ... it is not possible to state with certainty that there is a direct causal link between the actions of Artik Medical Centre personnel and the complications in question. ... taking into account [A.A.’s] narrow specialisation and in the absence of an orthopaedic trauma specialist, given the nature of [the applicant’s] trauma, her transfer to a medical facility with an orthopaedic trauma unit was required so that specialist medical care could be provided. However, taking into account the nature of the trauma received, it is not possible to make definitive predictions as to whether or not in such a case it might have been possible to avoid the development of such complications at the post-operative stage. ... based on the medical records submitted and the material in the criminal case file, it is not possible to conclude definitively that [the applicant’s] post-operative complications ... resulted from failures, omissions or errors on the part of the medical personnel of Artik Medical Centre. ... in view of [Dr A.A.’s] specialisation ... and the nature of [the applicant’s] trauma, [Dr A.A.’s] duty was to ensure emergency first-aid medical assistance (immobilisation of the fracture, administration of analgesics ...). As regards [the applicant’s] specialist treatment ... it was not within the scope of [Dr A.A.’s] specialist qualification but could be more suitably provided by an orthopaedic traumatologist. The provision at Artik Medical Centre of this type of medical assistance by a surgeon who was not a qualified orthopaedic traumatologist is an organisational failure which, however, as noted above, in this case is not directly linked to the development of the complications ...” 37 .     In response to an earlier enquiry by the investigator, by a letter of 14   August 2015 the Ministry of Health submitted, in particular, as follows: “... there are currently no unified legal acts setting out treatment guidelines and the rights and obligations of medical personnel of healthcare facilities, particularly those of a surgeon and traumatologist. A draft order of the Minister of Health on establishing the organisation of general surgical services is being prepared.” Termination of the investigation and the applicant’s appeals 38 .     On 18 September 2015 the investigator decided to terminate the criminal proceedings referring to, inter alia , the results of the additional forensic medical examination and Dr A.A’s additional statement (see paragraphs 35 and 36 above). The investigator’s decision stated, among other things, that in the course of the investigation the Ministry of Health had submitted that there were no legal acts regulating the activity of medical staff, particularly that of surgeons and traumatologists (see paragraph 37 above). Furthermore, according to information provided by the Shirak regional authority, the metal implants used during the applicant’s surgery had not been acquired by Artik Medical Centre. In 2008 there had been no legal provisions specifying whether the sourcing of metal implants was the responsibility of the patient or the medical facility. It could not therefore be concluded that Dr   A.A. was liable for any unlawful action. 39 .     The applicant appealed against the investigator’s decision to the prosecutor, arguing, in particular, that it had not been clarified whether Dr   A.A. had had the right to use the metal implants returned to him by another patient about a year before the applicant’s surgery, whether those metal implants had been of a State-approved standard and good for use and whether there was a link between Dr A.A.’s actions and the complications that she had experienced. The appeal was dismissed by a decision of 15 October 2015 which stated, in particular, that it had been established during the investigation that A.A., as a doctor by profession, had had the right to perform the surgery, that the applicant’s diagnosis had been correct and that the recommended surgery had corresponded to her diagnosis. 40 .     The applicant lodged a court complaint against the investigator’s decision of 18 September 2015, which was upheld by the prosecutor on 15   October 2015. 41 .     On 24 December 2015 the Regional Court upheld the investigating authority’s decision to terminate the criminal proceedings on the grounds that it had not been established during the investigation that there was a direct causal link between Dr A.A.’s actions and the damage to the applicant’s health. In doing so, the Regional Court referred to the medical report of 15   July 2015 (see paragraph 36 above). 42 .     The applicant lodged an appeal. She raised similar arguments as before. 43 .     On 16 February 2016 the Criminal Court of Appeal dismissed the applicant’s appeal, finding, in particular, that no link could be established between the applicant’s post-surgical complications and the fact that she had been operated on by a surgeon who was not a qualified orthopaedic traumatologist which, as had been established, was an organisational failure on the part of the hospital. As regards the use of metal implants not obtained either by the hospital or the applicant, the Court of Appeal referred to the statement of Artik Medical Centre, according to which there had been no legal provisions in place at the relevant time specifying whether the sourcing of metal implants was the responsibility of the patient or the medical facility. 44 .     The applicant lodged an appeal on points of law. She reiterated her previous arguments with regard to negligence on the part of Dr A.A., the latter’s lack of relevant qualifications and his failure to provide her with information about the surgery and its possible complications. The applicant asked the Court of Cassation to determine, inter alia , whether the absence of relevant State regulations at the material time could be interpreted as being favourable for a medical practitioner who had acted outside the scope of his qualifications. 45 .     The applicant’s appeal on points of law was declared inadmissible for lack of merit by a decision of the Court of Cassation of 4 May 2016. The applicant’s representative in the domestic proceedings received that decision on 14 July 2016. RELEVANT LEGAL FRAMEWORK AND PRACTICE Relevant domestic law and practice Liability for medical negligence and the right to compensation 46 .     Armenian law does not provide a specific set of rules and principles concerning civil or disciplinary liability for medical negligence. The law does not define the concept of “medical error” or “medical malpractice”. There are no professional disciplinary bodies competent to examine cases of medical negligence. Provisions relating to liability for medical negligence and the right to compensation are found in the Criminal Code, the Medical Care and Services of the Population Act and the Civil Code. Criminal Code 47 .     Medical negligence is a criminal offence under Article 130 § 1 of the Criminal Code, which provides that failure to perform or improper performance of professional duties by medical and support personnel as a result of negligence or bad faith, which has negligently caused serious or moderately serious damage to the patient undergoing treatment, is punishable by a fine of one hundred to two hundred times the minimum salary or a maximum of three months’ detention. Medical Care and Services of the Population Act 48 .     The relevant provisions of the Medical Care and Services of the Population Act adopted on 4 March 1996 (hereinafter “the Medical Care Act”) provide as follows: Section 1: Basic concepts “... 2. Providers of medical care and services: private entrepreneurs or legal entities providing a certain type or types of medical care and services, licensed in accordance with the legislation of the Republic of Armenia, irrespective of their legal and organisational structure, legal status and type of ownership, or public or community establishments which are not State or local governance bodies. ” Section 6: Right to receive compensation for damage sustained during the provision of medical care and services “Everyone shall have the right to receive compensation for damage caused to his or her health during the organisation and performance of medical care and services in accordance with the legislation of the Republic of Armenia.” Section 18: Medical care and service providers and their rights “Providers of medical care and services in the Republic of Armenia shall have the right to provide appropriate medical care and services of selected types if they have obtained a licence to do so. Individuals who have received the relevant education and specialisation in the Republic of Armenia and who hold a licence to practise certain types of medical activity in accordance with the procedure established by the legislation of the Republic of Armenia shall have the right to perform medical activity. Individuals who have received medical education in other countries shall be allowed to carry out medical activity in the Republic of Armenia in accordance with the procedure established by the Government of the Republic of Armenia in compliance with the relevant international treaties ratified by the Republic of Armenia. Providers of medical care and services ... shall have the right to ... insure their professional activity.” Section 19: Obligations and responsibility of medical care and service providers “Providers of medical care and services must ... ensure compliance of medical care and services being provided with the established quantitative and qualitative standards ... Providers of medical care and services, as well as individuals engaged in unlawful medical activity, shall be liable in accordance with the legislation of the Republic of Armenia for damage caused to a person’s health through their own fault ...” Civil Code 49 .     The relevant provisions of the Civil Code, as in force at the time material time, provide as follows. 50 .     Under Article 17 § 1, a person whose rights have been violated may claim full compensation for the damage suffered, unless the law or contract provides for a lower amount of compensation. Damage is the expenses borne or to be borne by the person whose rights have been violated, in connection with restoring the violated rights, loss of property or damage to it (material damage), including loss of income, as well as non-pecuniary damage (Article 17 § 2). Under Article 17 § 4, non-pecuniary damage may only be compensated in the cases provided for by the Civil Code (see paragraphs   52 and 57 below). 51 .     Article 129 § 1 provides that State bodies can appear in court on behalf of the State within the scope of their powers. 52 .     Article 162.1 § 2 provides that a person has the right to claim compensation for non-pecuniary damage if it has been established by the prosecuting authority or a court that, as a result of a decision, action or omission of a State or local governance body or one of its officials, a person’s right to, inter alia , respect for his private life has been violated. 53 .     Article 332 provides for a general statutory limitation period of three years. 54 .     Article 344 sets out a list of types of civil claim to which the statutory limitation period does not apply. That list includes claims concerning compensation for damage caused to an individual’s life and limb. However, where such claims are lodged more than three years after the right to claim compensation has arisen, they can be allowed only in respect of the three ‑ year period preceding the lodging of the claim. 55 .     Article 1058 § 1 provides that damage caused to a person or his or her property, as well as damage caused to the property of a legal entity, is to be compensated in full by the person who has caused such damage. A person not responsible for causing the damage may also be liable for compensation where stated by law. A person who has caused damage is exempted from paying compensation if it is established that the damage was caused through no fault of his or her own (Article 1058 § 2). 56 .     Article 1062 § 1 states that a legal person must compensate damage caused by its employees during the performance of work (service, official) duties. 57 .     Article 1087.2 §§ 3 and 4 provide that non-pecuniary damage suffered as a result of a violation of fundamental rights is to be compensated, irrespective of whether there is any fault on the part of a State official. Non ‑ pecuniary damage is compensated from the State budget. If the fundamental right included in Article 162.1 (see paragraph 52 above) has been violated by a local governance body or one of its officials, non ‑ pecuniary damage is compensated from the relevant local budget. The amount of compensation for non-pecuniary damage suffered as a result of a violation of a person’s right to respect for his or her private life shall not exceed two thousand times the minimum salary (Article 1087.2 §   7   (2)). The amount of compensation for non-pecuniary damage may, in exceptional cases, exceed the limit set out in paragraph 7 if the damage has had serious consequences (Article 1087.2 § 8). A claim for compensation for non ‑ pecuniary damage may be submitted to a court together with a claim seeking to establish a breach of the rights set out in Article 162.1 (see paragraph 52 above), within one year of the time the person became aware of the breach, as well as within six months of the date on which the judicial decision establishing the breach of the right in question came into force. If the breach has been established by a law-enforcement body, the claim for compensation for non-pecuniary damage may be submitted no earlier than two months but no later than one year after the date on which the person concerned became aware of the matter (Article 1087.2 §   9). 58 .     Since 1 November 2014 Article 17 § 2 (see paragraph 50 above) has included non ‑ pecuniary damage in the list of types of civil damage for which compensation can be claimed in civil proceedings. As a result, the Civil Code was supplemented by new Articles 162.1 and   1087.2 (see paragraphs 52 and 57 above), which regulate the procedure for claiming compensation for non-pecuniary damage from the State for a violation of certain rights guaranteed by the Armenian Constitution and the Convention. Until the introduction of further amendments on 30 December 2015 (in force from 1 January 2016), compensation in respect of non-pecuniary damage could be claimed from the State where it had been established by a judicial ruling that a person’s rights guaranteed by Articles 2, 3 and 5 of the Convention had been violated, as well as   in cases of wrongful conviction. As a result of the amendments that entered into force on 1 January 2016, compensation for   non-pecuniary damage could be claimed from the State for the finding of breach of a number of other rights, including those guaranteed under Article 8 of the Convention. Informed consent 59 .     The relevant provisions of the Medical Care Act, as in force at the material time, read as follows: Section 5: Rights of a person when receiving medical care and services “When requesting and receiving medical care and services, everyone shall have the right to: (a) choose a medical care and service provider; ... (d) be informed about his or her disease and give consent to medical intervention; (e) refuse medical intervention, except in the cases stipulated by this Law ...” Section 7: An individual’s right to information concerning his or her state of health “Everyone shall have the right to easy access to information as to the state of his or her health, the results of examinations, the methods of diagnosis and treatment of the disease and related risks, the possible options for medical intervention, the consequences and results of treatment ...” Section 8: Consent to medical procedures “A person’s consent is a necessary precondition for a medical procedure, except in the cases stipulated by this Law. At the request of the practitioner or the patient, consent may be in writing.” Section 16: Medical care and services without a person’s consent “It shall be permitted to provide medical care and services without the consent of the patient or his or her legally authorised representatives in cases of life-threatening disease and in cases of disease posing a danger to the health of others in accordance with the legislation of the Republic of Armenia.” Administrative procedure 60 .     Under Article 3 § 1 of the then Code of Administrative Procedure, a person had the right to apply to the administrative court if he or she considered that his or her rights guaranteed by the Constitution, international treaties, laws and other legal acts had been or could have been violated as a result of administrative decisions, action or omissions of State or local governance bodies or their officials. 61 .     The relevant provisions of the Fundamentals of Administration and Administrative Procedure Act state as follows: Section 3: Basic concepts “The basic concepts used in this Act are defined as follows: (1) administrative bodies: central and territorial governance bodies of the Republic of Armenia, as well as local governance bodies: (a) central governance bodies of the Republic of Armenia: ministries... and other State bodies exercising administrative power [administration] in the territory of [Armenia]; (b) territorial governance bodies: governors ( մարզպետներ ); (c) local governance bodies: community council and head of community ... If there are State bodies other than those listed exercising administrative power [administration], they shall be considered administrative bodies for the purposes of this Act; (2) administration: action of administrative bodies having external effect resulting in the adoption of administrative or normative decisions, as well as action or inaction which have actual consequences for individuals.” Section 53: Definition and types of administrative decision ( վարչական ակտ ) “1. An administrative decision is a decision, instruction, order or other individual legal action having external effect adopted by an administrative body for the purposes of regulating a specific case in the field of public law, and is directed to the prescription, amendment, elimination or recognition of rights and obligations for individuals.   ... 2. For the purposes of this Act: (a)     a favourable administrative decision is a decision by which administrative bodies confer rights on individuals or create any other condition that improves the legal or factual situation of those individuals, (b)     an unfavourable administrative decision is an administrative decision by which administrative bodies refuse, interfere, restrict the enjoyment of the rights of individuals, impose any obligation on them or in any other way worsen their legal or factual situation, (c)     a combined administrative decision is an administrative decision which combines both the favourable and unfavourable provisions contained in administrative decisions.” Section 54: Forms of administrative decision “1. As a rule, an administrative decision is adopted in writing as a decision, order, instruction or other form as provided for by the law. Only a written administrative decision may be adopted as a result of administrative proceedings instituted on the basis of a complaint. ...” Section 55: Requirements in respect of a written administrative decision “... 4. A written administrative decision should contain the following: ... (h)     the period for contesting the administrative decision and the body, including the court, to which the administrative decision may be appealed; ... (j)     the official stamp of the administrative body which has adopted the administrative decision.” Relevant domestic case-law 62 .     The Government provided two examples of domestic court practice in which the issue of civil liability for medical malpractice was examined. They included, in particular, the following judgments: 1.     Kentron and Nork-Marash District Court of Yerevan, case no.   ԵԿԴ /2601/02/11, judgment of 2 November 2012; and 2.     Avan and Nor-Nork District Court of Yerevan, case no.   ԵԱՆԴ /0510/02/13, judgment of 16 September 2014. The first case concerned the plaintiff’s claim against a private clinic and two private hospitals as co-defendants seeking compensation for damage and costs and expenses sustained as a result of a medical error during surgery performed at the defendant private clinic and the subsequent treatment she had to undergo in the co-defendant hospitals. The plaintiff also complained that the doctor at the defendant clinic had not provided her with full and accurate information about the nature of the surgery and its possible risks, and had performed more extensive surgery without her consent. The civil claim was lodged shortly after criminal proceedings relating to the same allegations had been suspended for an indefinite period on the grounds that it had been impossible to identify the person to be charged. Referring to the material in the criminal case file, including the relevant expert reports, the civil courts dismissed the claims, finding that no causal link could be established between the relevant medical professionals’ guilt and the damage sustained by the plaintiff. The courts also found that the plaintiff had been properly informed of the nature and possible complications of the surgery prior to signing the general consent form and that the decision to perform more extensive surgery had been based on medical necessity which had arisen during the surgery. The second case concerned a claim by a plaintiff who sought to recover the amount of her payment made to a private entity practising non-traditional treatment methods, on the grounds that her daughter’s hearing function had not improved after the relevant treatment, contrary to what had been promised initially. The examination of the case was suspended by the civil court for several months until the criminal proceedings relating to the same facts were terminated. The plaintiff’s claims were dismissed on the grounds that, inter alia , it had not been established that any damage had been caused to her daughter’s health, and that she had paid the amount in question voluntarily. 63 .     The Government also provided several examples of recent domestic practice concerning compensation in respect of non-pecuniary damage for violations of Convention rights. Those examples concerned, in particular, cases of established violations of the rights guaranteed under Articles 5 and   6 of the Convention. In all cases, the domestic courts’ awards in respect of non-pecuniary damage were based either on another judicial decision establishing a violation of the person’s right guaranteed by the Convention or a decision of the investigating authority terminating the proceedings against the person on exonerating grounds. Furthermore, in one of the cases relied on by the Government (Ajapnyak and Davtashen District Court of Yerevan, case no.   ԵԱԴԴ /3611/02/14, judgment of 10 February 2016) the domestic court dismissed the claim in respect of non-pecuniary damage on the grounds that, inter alia , the claimant had failed to submit a decision of the court or investigating authority establishing that there had been a violation of a Convention right as a result of a decision, action or omission on the part of a State or local governance body or one of its officials. Relevant international law 64 .     Article 5 of the Council of Europe Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine (Convention on Human Rights and Biomedicine) reads as follows: “An intervention in the health field may only be carried out after the person concerned has given free and informed consent to it. This person shall beforehand be given appropriate information as to the purpose and nature of the intervention as well as on its consequences and risks. The person concerned may freely withdraw consent at any time.” 65 .     Paragraph 35 of the Explanatory Report to the Convention on Human Rights and Biomedicine states as follows: “The patient’s consent is considered to be free and informed if it is given on the basis of objective information from the responsible health care professional as to the nature and the potential consequences of the planned intervention or of its alternatives, in the absence of any pressure from anyone. Article 5, paragraph 2, mentions the most important aspects of the information which should precede the intervention but it is not an exhaustive list: informed consent may imply, according to the circumstances, additional elements. In order for their consent to be valid the persons in question must have been informed about the relevant facts regarding the intervention being contemplated. This information must include the purpose, nature and consequences of the intervention and the risks involved. Information on the risks involved in the intervention or in alternative courses of action must cover not only the risks inherent in the type of intervention contemplated, but also any risks related to the individual characteristics of each patient, such as age or the existence of other pathologies. Requests for additional information made by patients must be adequately answered.” THE LAW ALLEGED VIOLATION OF ARTICLE 8 OF THE CONVENTION 66.     Relying on Article 8 of the Convention, the applicant complained that her disability had resulted from inadequate medical care received at Artik Medical Centre. She also complained that there had been no specific regulations relating to orthopaedic surgery in force at the relevant time and that she had not been informed of the nature and risks of the procedure before her operation. She lastly complained of the lack of an effective mechanism enabling her to hold accountable those at fault and obtain adequate redress. Article 8 of the Convention reads as follows: “1.     Everyone has the right to respect for his private and family life, his home and his correspondence. 2.     There shall be no interference by a public authority with the exercise of this right except such as is in accordance with the law and is necessary in a democratic society in the interests of national security, public safety or the economic well-being of the country, for the prevention of disorder or crime, for the protection of health or morals, or for the protection of the rights and freedoms of others.” Admissibility The parties’ submissions 67.     The Government raised two objections in connection with the applicant’s complaints. 68 .     Firstly, they submitted that the complaint concerning failure by the State to establish relevant regulations compelling hospitals to adopt appropriate measures for the protection of patients’ physical integrity had been lodged outside the six-month time-limit. They contended that the applicant should have become aware of the level of the State’s compliance with its positive obligation to have in place relevant regulations following the consultations held at the Department of Health, that is to say by 4 October 2010, the date of the second consultation (see paragraph 18 above). The applicant had failed to challenge the results of those consultations. Had she considered that taking any further action to challenge the results of the consultations in question would be ineffective, she should have lodged her complaint within six months from the date of the second consultation at the latest. 69.     The applicant did not make any submissions in this connection. 70 .     Secondly, the Government raised an objection concerning exhaustion of domestic remedies in various aspects. Firstly, they submitted that the applicant had failed to challenge the results of the consultations held by the Department of Health (see paragraphs 16 and   18 above). They argued that she could have appealed against the findings of those consultations as an administrative decision before the administrative court. Secondly, the Government stated that the applicant had failed to lodge a civil claim for damages against Artik Medical Centre, it being a publicly funded healthcare facility, or the State.